CMDv TEM 023e template worksharing letter of intent by 12lsX9q

VIEWS: 17 PAGES: 2

									                                                                                <Date>

                                                                 < Company Reference>

To:
CMDv Secretariat
European Medicines Agency


CMDv@ema.europa.eu



Subject:        Letter of intent for the submission of a worksharing procedure to
                the CMDv

                according to   Article   20   of   Commission    Regulation    (EC)   No
                1234/2008

                ‘informal’  worksharing   procedure      (tick    this   box    if    any
                purely-national MAs are included)



Worksharing Applicant details:


           Name



         Address




Contact person details
  (i.e. name, address,
 email address, phone
 number, fax number)




Application details:
This letter of intent for the submission of a <Type IB> <Type II> <group of variations>
following an (informal) worksharing procedure concerns the following medicinal products:


a) List of marketing authorisations concerned:

Product              Active              Member       MA holder          MA number /
(Trade name)         substance           State        name               MRP/DCP no.




CMDv-TEM-023e
b) Description of the changes
The following variation(s) are intended to be part of the worksharing procedure:
Number as in the
                          Title of variation as in the classification    Type of
classification
                          guideline                                      variation
guideline




<Include here a description of the changes>
<if grouping is proposed, a justification should be provided>


c) Preferred Reference Authority




d) Justification as to why the MAH believes that a worksharing procedure is
   suitable




e) Intended submission date




f) Explanation that all MAs concerned belong to the same holder




g) If applicable, details of submission/approval/rejection               of   the   same
   variation(s) in any Member State(s)




<Signature>




CMDv-TEM-023e

								
To top